MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. OPTIPAC 60 REFOBACIN BONE CEMENT R; BONE CEMENT, ANTIBIOTIC

Catalog Number 4711500396-3

Device Problem Improper Chemical Reaction (2952)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign report source: (b)(6).The review of the device manufacturing quality record indicates that 1 825 products optipac 60 refobacin bone cmt r-3, reference 4711500396-3, lot number 851ea05645 were manufactured on 5 february 2019.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Root cause was unable to be determined at this time, pending investigation results.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

Event Description

It was reported that during surgery hardening time of the cement of an optipac 60 was extended.The doctor was unsatisfied with the hardening time of an optipac 60.The storage temperature and the room temperature were 20 degrees celsius and the hardening time of the cement in site was 15 minutes.This is 5 minutes longer than the reference.The surgery was finished with the same device but there was a delay of 10 minutes.No adverse event has been reported.

Manufacturer Narrative

(b)(4).G3 - report source, foreign - event occurred in (b)(6).The device was not returned to the manufacturer.Therefore it could not be analyzed.Reserve sample from the same lot has been tested in the laboratory under standardized conditions (22,3°c; rel.Humid >=40 %).It has been found that no unusual behavior during mixing, handling or setting.The reported behavior of the cement cannot be reproduced.The review of the device manufacturing quality record indicates that (b)(4) products optipac 60 refobacin bone cement r-3, reference (b)(4), lot number 851ea05645 were manufactured on 5 february 2019.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.Within one year, no similar complaints have been recorded for optipac 60 refobacin bone cement r-3, reference (b)(4), batch 851ea05645 regarding a too long setting time.According to the available data, the exact root cause of the event cannot be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that during surgery hardening time of the cement of an optipac 60 was extended.The doctor was unsatisfied with the hardening time of an optipac 60.The storage temperature and the room temperature were 20 degrees celsius and the hardening time of the cement in site was 15 minutes.This is 5 minutes longer than the reference.The surgery was finished with the same device but there was a delay of 10 minutes.No adverse event has been reported.

• Brand Name: OPTIPAC 60 REFOBACIN BONE CEMENT R
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 9185054
• MDR Text Key: 216674834
• Report Number: 3006946279-2019-00415
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 4711500396-3
• Device Lot Number: 851EA05645
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1